从胶囊制剂铬超标浅析质量体系在原材料质量控制中的作用

Actions of quality control for purchased material arising chromium from gelatin capsules

讨论《药品生产质量管理规范》《药用辅料生产质量管理规范》以及ISO9001质量管理体系认证对原料控制、供方评价、质量管理职责等要求。通过分析胶囊制剂铬限量超标现象,加强原料质量控制、供应商定期评价和再评价管理以及各类标准对铬的技术要求。质量控制中,人员的责任心起着决定性作用,必须树立药物安全性是第一要素,生产者是质量第一责任人的意识。

It was discussed on demands for evaluating,selecting supplier,quality control for purchased raw ntaterial,duty of quality manager in certificate to Good Manufacturing Practice for Drug and Good Manufacturing Practice for Pharmaceutical Adjuvant and Quality Management Systems （ISO 9001）,going beyond chromium limited in gelatin capsules.It was necessary to select,evaluate and re-evaluate suppliers uninterruptedly in accordance with requirements for product realization by oneself.It was the responsibility that pay finality role in quality control for top management,it must be emphasized that manufacturer is the first person in charge of quality,and that hygiene is first considered for drug and pharmaceutical adjuvant to enhance quality management and control quality of purchased products.